Med Prep Drug Facility Plagued By Safety Risks Is Shut Down
Last year, a fungal meningitis outbreak claimed the lives of numerous citizens from around the country and compromised the safety and health of many more. The Food and Drug Administration ratcheted up their compounding pharmacy regulatory efforts as a result, conducting a series of inspections that even led to 14 recalls. These were issued due to a potential lack of sterility akin to what led to the aforementioned outbreak in the first place.
FDA’s inspection efforts brought them to a Tinton Falls, New Jersey-based plant run by Med Prep Consulting. The results of the inspection were eye-opening. The pharmacy reportedly failed to follow good manufacturing practices even as conditions at the plant may have contributed to sanitation shortfalls. That’s not all. The FDA discovered that some of the drugs on hand did not include sufficiently high amounts of active drug ingredients. What the samples did contain was mold.
As if these violations weren’t enough, the FDA also states that Med Prep has been creating and shipping drug products without bothering to first obtain a new drug application or a patient prescription.
As a result of these circumstances, the FDA has asked for and received a consent decree of permanent injunction against the company from a judge. Until the pharmacy meets the requirements of the law, they will be barred from producing and distributing drugs.
All their sterile products have already been recalled at this point, and thankfully no one has reported sustaining an illness.